Ibuprofen Versus Indomethacin Following Emergent Cerclage Placement

NCT04726085 | Terminated

• 1 other identifier: RP-20-028
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

Cervical insufficiency is defined as painless cervical dilation in the second trimester. Cervical insufficiency can ultimately lead to second trimester loss of pregnancy. Cerclages are utilized in pregnancies affected by cervical insufficiency in order to prolong gestational latency. There have been several studies investigating the efficacy of perioperative medications for cerclage placement and the effects they have on gestational latency. Some such studies have found that perioperative indomethacin in combination with antibiotics have significantly increased gestational latency when compared to placebo. Indomethacin has traditionally been the tocolytic of choice with cerclage placement. At our hospital, ibuprofen has been the tocolytic of choice for cerclage placement secondary to pharmacy availability. Our study aims to evaluate whether gestational latency differs among patients undergoing emergent cerclage whether they receive perioperative ibuprofen or indomethacin.

Conditions

Preterm Labor

Keywords

cerclage

Outcome Measures

Primary Outcomes (1)

• Gestational latency

  Days from cerclage placement to delivery, assessed up to 26 weeks

  From cerclage placement to delivery

Secondary Outcomes (1)

• Preterm birth

  At delivery

Study Arms (2)

Ibuprofen

ACTIVE COMPARATOR

Ibuprofen 600 mg q6 hours for 24 hours- total dose of 2400mg- after emergent cerclage placement

Drug: Ibuprofen 2400mg

Indomethacin

ACTIVE COMPARATOR

Indomethacin 50 mg q8 hours for 24 hours- total dose of 150mg- after emergent cerclage placement

Drug: Indomethacin 150mg

Interventions

Indomethacin 150mg DRUG

Patients will be randomized to either received perioperative indomethacin or ibuprofen at the time of their emergent cerclage placement for 24 hours following surgery. Patient will be followed up through our electronic medical record system to determine gestational latency to evaluate if ibuprofen is inferior to indomethacin.

Indomethacin

Ibuprofen 2400mg DRUG

Patients will be randomized to either received perioperative indomethacin or ibuprofen at the time of their emergent cerclage placement for 24 hours following surgery. Patient will be followed up through our electronic medical record system to determine gestational latency to evaluate if ibuprofen is inferior to indomethacin.

Ibuprofen

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Viable, singleton pregnancy
• ≥ 18 years old
• Gestational age 16 weeks 0/7 days - 23 week 6/7 days (inclusive)
• Intact membranes at time of enrollment
• Planning to deliver at Woman's Hospital
• Exam or ultrasound indicated cerclage placement

You may not qualify if:

• Contraindication to treatments (i.e. ibuprofen or indomethacin)
• Unwilling to be randomized to treatment
• Prophylactic cerclage placement
• Temperature greater than 100.4
• Known major fetal congenital anomaly
• Prior cerclage placement during the current pregnancy
• Recent (within 7 days) receipt of ibuprofen or indomethacin

Sponsors & Collaborators

• Woman's: lead

Study Sites (1)

Woman's Hospital

Baton Rouge, Louisiana, 70817, United States

Location

MeSH Terms

Conditions

Obstetric Labor, Premature

Interventions

Indomethacin; Ibuprofen

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Pamela Simmons, DO

  Woman's Hospital, Louisiana

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2021
• First Posted: January 27, 2021
• Study Start: February 1, 2021
• Primary Completion: November 6, 2023
• Study Completion: November 6, 2023
• Last Updated: August 6, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)